One of the most convenient methods of administering medicine in small amounts is to package the medicine in a pre-filled, pre-determined amount. This not only makes the administering of the medicine easier, but also helps insure against accidental over-dosing. Unfortunately, many medicines are still packaged and stored by older, conventional means. If there were some way of packaging, storing and administering low-dose medicine, in an easy-to-use manner, it would be beneficial to many people.
In hospitals today, there is a high demand for pre-packaged unit-doses for all liquid “over the counter” (“OTC”) medicines and liquid drug products. A paper by the Center for Innovation in Healthcare Logistics published Dec. 23, 2008, stated that “the option preferred by 85% of hospital pharmacy directors is to purchase medications directly from the manufacturer in unit-dose form.” Some liquid medications are available to hospital pharmacists in pre-packed unit doses, but these packages are generally multiple piece parts that are primitive and somewhat awkward. In addition, many hospitals today actually make their own unit doses from larger bottles by hand, one at a time, in the pharmacies themselves, or hire yet another company to do this service for them. Compared to all of these options available to hospital pharmacists, a Unit-Dose Delivery Systems (“UDDS”) for liquids, creams and gels solution is not only more efficient, but it is also safer, reduces potential errors, provides a longer shelf life, and will be less expensive in most instances.
Liquid medicine doses are typically administered using one of four measured quantities: teaspoon, cup, dropper or syringe. The dosing amounts are listed on a table located on the outside of a carton or the device for a given age and/or weight of a person, with the table normally specifying the correct dose. Because of differing methods of administration and the range of doses, the tables can be difficult for the end user to understand. The traditional four delivery methods used for oral medications are as follows:
A spoon is the most traditional method of delivery where the user fills the spoon with the prescribed amount of liquid and inserts the spoon into a patient's mouth. The advantage of this method is that spoons are convenient. A disadvantage is that spoons are shallow, thus making it difficult to not spill the liquid when pouring out the proper amount. Also, a spoon is imprecise as to measurement. Perhaps more importantly, it may be very troublesome to convey the liquid into an unwilling child's mouth without spilling at least some or all of the medication in the process.
Sensing the need for a delivery method that allows administering medication away from the home, manufacturers began marketing products that included a plastic cup with the packaging of the medication. The plastic cup included calibration marks corresponding to the recommended doses and could be reused after washing. The advantage of this system is that it may be used at any location, it is accurate, neat to use, and simple to understand. The downside is that after use the cup may have a coating of medication on the inside and must be washed, this may be problematic if there is no water available at the time. Further, if the cup is not cleaned expeditiously, the remaining contents could become sticky and hard to clean. Another disadvantage is the potential for cross contamination from one user to another. Also, it is commonly difficult to read the gradations of volume, and are hard to transport.
The dropper method is often used for administration of liquid medicine to infants or small children. The dropper shaft is usually marked for the dosage, for ease of filling from a bottle. The dropper is then placed in the patient's mouth and the bulb is squeezed to release the medication. The dropper is washed and is either placed into a carton or a medication bottle for storage. One advantage is that infants and small children may not be able to drink liquid from a cup therefore, medication may be easily released directly into their mouth. Another advantage is that this method may be used to administer medication to those who may have difficulty in taking pills. The downside is that droppers are difficult to sterilize using tap water exclusively and cross contamination is probable, particularly since the dropper must be inserted into the medication, sometimes multiple times, to obtain the proper dose. Further difficulty can arise when filling the dropper if the bottle is almost empty.
The dropper method has received increasing interest. Many liquid dispensers of the squeeze-bottle type have been developed for dispensing medicinal solutions in droplet form. Most conventional dispensers include a container formed from a resilient plastic material having an opening therein for producing drops of liquid which are dispensed from the container upon squeezing thereof.
Syringes also are used to administer liquid medicine. Disadvantages of syringes include inaccuracies in measurement and difficulty of use. An advantage is that syringes are well-known devices, especially in hospital environments.
Medications are often prescribed which must be dispensed in a metered amount over a predetermined period of time. The medication is typically packaged and marketed in containers enabling individual self-administrable dosages and the user typically self-administers the medication over a predetermined period of time. This is often the case in the field of ophthalmology wherein various forms of medication are frequently prescribed for the patient to be dispensed in metered drops from a disposable container. Any number of medications may be administered in this manner and such medications typically include decongestants, antibiotics, anti-inflammatories, anti-glaucomic medication, antibacterials, anesthetics, mydriatics, anti-cholinergics, antibiotics as well as combinations thereof.
Since the dispensed drops are to be metered, it is important that a predetermined volume of solution is dispensed per drop, and it is important that only one drop be dispensed per squeeze of the container. Naturally, the dispenser must be suitable for providing multiple doses or drops from a single container, and each of the drops must be of equal size.
Toward providing a predetermined medication, disposable pre-filled containers have been developed. For example, a pre-filled medication may be provided in a disposable plastic container, such as a pipette, dropper or other similarly shaped device to orally administer the liquid medication. The container may be sized to accommodate a specific amount of medication for oral administration in one dose.
Some liquid medications are available to hospital pharmacists in pre-packed unit doses, but these packages are generally in multiple piece parts that are primitive and somewhat awkward. In addition, many hospitals today actually make their own unit doses from larger bottles by hand, one at a time, in the pharmacies themselves, or hire yet another company to do this service for them. Compared to all of these options available to hospital pharmacists, a Unit-Dose Delivery Systems (“UDDS”) for liquids, creams and gels solution is not only more efficient, but it is also safer, reduces potential errors, provides a longer shelf life, and will be less expensive in most instances.
In one embodiment of the invention a UDDS is disclosed. Traditional medical delivery systems are deficient in a variety of ways. For example, the devices include and/or require disposable parts which may present a choking hazard to small children and the elderly, provide inaccurate dosage, are difficult to operate, may be cost prohibitive, and/or are of limited shelf life.
By way of example, Phillips in U.S. Pat. No. 5,926,662 (“Phillips”) teaches a drug delivery device that has a reservoir holding medicine for delivery to a patient. The device has a conduit with one end coupled to the reservoir and a free end to position within the fornix of a patient's eye. Through gravity and capillary action, the medicine flows into the eye with a rate of delivery adjusted according to the size and material of the conduit. The invention has the reservoir made of an absorbent material provided with an impermeable backing which acts as a barrier. In the preferred embodiment, the backing has an adhesive for attaching to the eye of the patient. Phillips is incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 5,799,837 issued to Firestone, et al. (“Firestone I”) is for a packaged pharmaceutical product having an extended shelf life and includes a container consisting of a hollow body with an open end. The body wall thickness enables drop-by-drop dispensing of a medicine by manually squeezing the container body. A tip is fixed to the body to form droplets for application. Firestone I is incorporated by reference in its entirety for all purposes.
Lifshey in U.S. Pat. No. 5,624,067 (“Lifshey”) discloses an ophthalmic storage and dispensing device formed by injection molding, consisting of a vial with thick rigid walls and a limited flexible area. The flexible area allows only a small displacement when squeezed, providing a metered volume of liquid. The tip has a integral-molded puncture membrane to provide sealing. Lifshey is incorporated by reference in its entirety for all purposes.
Firestone, et al. in U.S. Pat. No. 5,609,273 (“Firestone II”) teaches a barrier package that includes a container with a hollow body and an open end having a body thickness which enables a drop-by-drop dispensing of a medicant by manually squeezing the container. A dropper tip is fixed to the open end and forms droplets upon manual squeezing of the body. Firestone II is incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 5,578,020 issued to Mosley (“Mosley”) is for an eye drop dispenser and dispensing sleeve. The dropper has a liquid reservoir portion and a dispensing end with a dropper orifice. Part of the reservoir is resilient and a dispensing sleeve circumscribes the dropper tube with a pair of legs that extend beyond the end of the tube. The legs are adapted to fit against the orbital areas of an eye to support the dropper over the eye for application of the liquid. Mosley is incorporated by reference in its entirety for all purposes.
Fennimore in U.S. Pat. No. 4,150,744 (“Fennimore”) discloses a packaging device for light and oxygen sensitive liquid which includes a dropper spout. The vessel itself is sealed within a gas impermeable envelope under vacuum. Fennimore is incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 7,487,894 issued to Zahn et al. on Feb. 10, 2009 (“Zahn I”) and U.S. Pat. No. D534,648 issued to Zahn et al. on Jan. 2, 2007 (“Zahn II”) teach a dispensing container fillable with a liquid including a squeezable reservoir for holding the liquid prior to dispensing; a dispensing head which appears substantially flat in profile and which is integral with the squeezable reservoir and having a distal end and a proximal end and having a bottom surface and a top surface one or both of which has an indented portion; an outlet at the distal end of the dispensing head for dispensing the liquid from the container; a passage interconnecting the squeezable reservoir and the outlet; and a stop disposed near the proximal end of the dispensing head to prevent over-insertion of the dispensing head into a user's mouth when the container is used to dispense the liquid to the user. Containers that are pre-filled with liquid and a method of making the containers are also described. Zahn I and Zahn II are incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 6,457,612 issued to Zhang et al. on Oct. 1, 2002 (“Zhang”) teaches an improved pre-filled disposable pipette consisting of a hollow tube dimensioned to enclose a medicinal product and having attached a medication transfer tube from where the pipette is filled and the medicinal product released. The improvement consists in having a primary grasping tab attached to an upper end of the bulb; a secondary grasping tab attached to each side of the tube; and a support tab also attached to each side of the tube near the lower end of the tube. The primary and secondary grasping tabs allow the pipette to be conveniently and easily handled without having to grasp the sensitive bulb or to directly grasp the tube. The support tab functions to allow the pipette to be placed on a conveyor rack apparatus from where the pipette can be automatically filled and sealed by a cap or heat applied foil. Zhang is incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 2,252,119 issued to Edmonds et al. on Aug. 12, 1941 (“Edmonds”) teaches a design for a dispensing container. The Edmonds design features and requires a break-away tab that separates from the rest of the device. The tab must be removed to dispense the fluid contained in the device. Edmonds is incorporated by reference in its entirety for all purposes.
U.S. Pat. No. 3,993,223 issued to Welker et al. on Nov. 23, 1976 (“Welker”) teaches a sealed dispensing container for liquid medicaments is described which may be readily opened by a twisting force applied on opposite ends of the container. All of the parts of the container making up a chamber for the medicament are shaped to be substantially completely flattened by the application of a compressive force, such as that applied by thumb and forefinger, to completely discharge the liquid medicament. After the container is opened, the liquid will be retained in the container in the absence of a compressive force and regardless of the orientation of the container in a horizontal or inverted position. Welker is incorporated by reference in its entirety for all purposes.
International Pub. No. WO 2008/062203 published to Mcaffer et al. on May 29, 2008 (“Mcaffer”) teaches an ampoule made of plasties material, for liquid or suspension pharmaceuticals, has a reservoir linked to a removable head by a channel in a neck portion. The channel has a trap, thus located between its reservoir and the head, in the form of an elongated restriction and/or a bend to trap liquid or suspension which may settle during storage, and prevent either reaching the head. Mcaffer is incorporated by reference in its entirety for all purposes.
As mentioned, traditional medical delivery systems are deficient in a variety of ways. For example, the devices include and/or require disposable parts which may present a choking hazard to small children and the elderly, provide inaccurate dosage, are difficult to operate, are cost prohibitive, and/or are of limited shelf life. Therefore, there is a long-felt need for an efficient single-use delivery system for liquids, creams and gels. The delivery device is cost efficient and requires no detachable parts.